Teligent, Inc. announces first FDA generic approval of Hydrocortisone Butyrate Lotion 0.1%.
Teligent, Inc., a New Jersey-based specialty generic pharmaceutical company, announced it has received approval of the company’s abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) of Hydrocortisone Butyrate Lotion 0.1%. It is Teligent’s ninth approval for 2017, and its 19th approval from its internally developed pipeline of topical generic pharmaceutical medicines.
Based on recent QuintilesIMS Health data from September 2017, the total addressable market for this product is approximately $17.0 million.
“We submitted this ANDA on August 31, 2016, pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act),” Jason Grenfell-Gardner, president and CEO of the company, said. “As we were the first ANDA applicant to submit an ANDA with a paragraph IV certification for Hydrocortisone Butyrate Lotion, 0.1%, with this approval Teligent is eligible for 180 days of generic drug exclusivity for Hydrocortisone Butyrate Lotion, 0.1%. We expect to launch this product in the first quarter of 2018.”
Grenfell-Gardner aded that the company now has 24 topical generic pharmaceutical products and four injectable products in its U.S. portfolio.
(Source: Teligent Inc.)
Filed Under: Drug Discovery
